The Food and Drug Administration (FDA) announced Tuesday that naproxen, the active ingredient in Bayer’s Aleve and generic drugs like it, may carry a lower cardiac risk than other anti-inflammatory meds like Advil and Motrin, according to The Associated Press. The FDA suggests emphasizing the safety of naproxen on the product labels so that consumers know when they’re choosing a nonsteroidal anti-inflammatory drug (NSAID).
“All of these products have an issue or two, and I think this removes one of the scarlet letters from naproxen, which allows it to be marketed as safer in a cardiac sense,” said Ira Loss, a pharmaceutical analyst with Washington Analysis, according to Global News.
The FDA will reportedly hold a public meeting next month where the findings of a safety review of 350,000 patients taking various pain relievers will be presented, AP reported. The review found that naproxen doesn’t necessarily carry the same risks as similar medications in its class, which could make it one of the premier NSAID pain relievers among doctors and patients. Patients who took naproxen suffered heart attacks and strokes at lower rates than those who took other NSAIDs.
Naproxen is an NSAID used to relieve pain, tenderness, or swelling. Non-prescription naproxen, like Aleve, is used to mitigate pain from headaches, muscle aches, menstrual cramps, and other minor aches. It can be taken as a tablet, extended-release capsule, or in liquid form. Less well-known brands of naproxen include Anaprox, EC-Naprosyn, Naprelan, and Naprosyn.
For years NSAID pain relievers have been linked to increased risk of heart attack. People who use the medications regularly as well as those with heart disease have been found to be at a particularly increased risk of cardiac complications from using NSAIDs. The National Institutes of Health warns, “NSAIDs such as naproxen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or who drink three or more alcoholic drinks per day while taking naproxen.”
As you can see, this new research challenges what was previously thought about Aleve and medications like it. Of course, this new information doesn’t change the fact that Aleve and other NSAIDs still carry a risk of ulcer and internal bleeding. That side effect is believed to be responsible for 200,000 hospital visits each year. According to AP, the FDA’s memo simply urged for a modification in naproxen labeling “to reflect the more favorable cardiovascular risk profile” for the drug.